Senior Validation Engineer
Pfizer
September 02, 2026
On-site
Michigan, United States
Operations
Rochester Senior Validation Engineer
Responsibilities
- Plan, schedule, execute, and lead validation projects (qualification/validation/requalification) for manufacturing processes, equipment, critical utility systems, product, cleaning, and/or sterilization processes.
- Develop/author project plans, protocols, test scripts, and reports across the full process lifecycle (from initiation through continuous monitoring).
- Finalize validation/qualification requirements with area owners and suppliers while ensuring adherence to company policies, procedures, and applicable regulations.
- Troubleshoot; perform gap and risk assessments; support regulatory inspections; conduct training as required.
- Support validation/qualification of manufacturing equipment, facility, critical utilities, laboratory equipment.
- Support validation/qualification of product, cleaning, shipping, aseptic processing (media fill), and sterilization (steam) cycles.
- Develop/author and execute FRSs, URSs, FATs, SATs, DQ, IQ, OQ, PQ and other validation lifecycle documents.
- Develop/author validation master plans, SOPs/programs/policies, system impact assessments, risk assessments, validation/qualification protocols, and periodic requalification.
- Work cross-functionally to schedule and complete activities; support corrective actions for validation deviations.
- Support audit preparation and defend validation responsibility areas.
- Perform periodic process capability analysis for commercial processes; identify improvement areas.
- Support APQR sections; review site change controls; lead projects to reduce process risk and optimize productivity.
- Qualification required in aseptic gowning and cleanroom techniques (Grade A through D).
Qualifications (Basic)
- Bachelor’s degree + 2 years experience; OR Master’s + 0+ years; OR Associate’s + 6 years; OR High school (or equivalent) + 8 years relevant experience.
Preferred
- Validation/qualification knowledge for pharmaceutical processes, equipment, utilities, facilities, and/or computer systems.
- Experience with sterile products and medical devices.
- Analytical/problem-solving, organizational/time management.
- Mentoring/guide others; regulatory audit/compliance experience.
- Experience using common AI tools (e.g., ChatGPT, Microsoft Copilot) with awareness of responsible AI.
Physical/Mental
- Penicillin manufacturing facility: must not be allergic to penicillin.
- Must be able to aseptically gown.
- Lift 25–30 lbs.
Work Schedule/Travel
- Non-standard schedule may be required (weekends/second shift/night shift/calls).
- Minimal travel.
Application
- Last date to apply: September 15, 2026.
Responsibilities
- Plan, schedule, execute, and lead validation projects (qualification/validation/requalification) for manufacturing processes, equipment, critical utility systems, product, cleaning, and/or sterilization processes.
- Develop/author project plans, protocols, test scripts, and reports across the full process lifecycle (from initiation through continuous monitoring).
- Finalize validation/qualification requirements with area owners and suppliers while ensuring adherence to company policies, procedures, and applicable regulations.
- Troubleshoot; perform gap and risk assessments; support regulatory inspections; conduct training as required.
- Support validation/qualification of manufacturing equipment, facility, critical utilities, laboratory equipment.
- Support validation/qualification of product, cleaning, shipping, aseptic processing (media fill), and sterilization (steam) cycles.
- Develop/author and execute FRSs, URSs, FATs, SATs, DQ, IQ, OQ, PQ and other validation lifecycle documents.
- Develop/author validation master plans, SOPs/programs/policies, system impact assessments, risk assessments, validation/qualification protocols, and periodic requalification.
- Work cross-functionally to schedule and complete activities; support corrective actions for validation deviations.
- Support audit preparation and defend validation responsibility areas.
- Perform periodic process capability analysis for commercial processes; identify improvement areas.
- Support APQR sections; review site change controls; lead projects to reduce process risk and optimize productivity.
- Qualification required in aseptic gowning and cleanroom techniques (Grade A through D).
Qualifications (Basic)
- Bachelor’s degree + 2 years experience; OR Master’s + 0+ years; OR Associate’s + 6 years; OR High school (or equivalent) + 8 years relevant experience.
Preferred
- Validation/qualification knowledge for pharmaceutical processes, equipment, utilities, facilities, and/or computer systems.
- Experience with sterile products and medical devices.
- Analytical/problem-solving, organizational/time management.
- Mentoring/guide others; regulatory audit/compliance experience.
- Experience using common AI tools (e.g., ChatGPT, Microsoft Copilot) with awareness of responsible AI.
Physical/Mental
- Penicillin manufacturing facility: must not be allergic to penicillin.
- Must be able to aseptically gown.
- Lift 25–30 lbs.
Work Schedule/Travel
- Non-standard schedule may be required (weekends/second shift/night shift/calls).
- Minimal travel.
Application
- Last date to apply: September 15, 2026.